Device and method for determining information related to a medical device

ABSTRACT

The invention relates to an apparatus ( 2, 3 ), comprising a mating unit ( 20 - 1, 20 - 2 ) for releasably attaching the apparatus ( 2 ) to a medical device ( 1 ) or for releasably receiving at least a part of the medical device ( 1 ). The apparatus ( 2, 3 ) further comprises one or more optical sensors ( 25, 26 ) and/or one or more acoustical sensors ( 27 ) for determining information related to a condition and/or use of the medical device ( 1 ). The invention further relates to a system comprising such an apparatus ( 2, 3 ) and such a medical device ( 1 ), to a method ( 500, 600, 700 ) and a computer program ( 61 ) for determining information related to a condition and/or use of such a medical device ( 1 ), and to a computer-readable medium ( 60 ) storing such a computer program ( 61 ).

CROSS REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 14/791,293 filed Jul. 3, 2015, which is a continuation of Ser.No. 13/583,948 filed Feb. 13, 2013 which has issued as U.S. Pat. No.9,125,991 on Sep. 8, 2015,which is a U.S. National Phase Applicationpursuant to 35 U.S.C. § 371 of International Application No.PCT/EP2011/054283 filed Mar. 22, 2011 which claims priority to EuropeanPatent Application No. 10157233.7 filed Mar. 22, 2010, the entirecontents of which are incorporated entirely herein by reference.

FIELD OF THE INVENTION

The present invention relates to an apparatus, a method and a computerprogram for determining information related to a condition and/or use ofa medical device, for example a medical device configured to eject amedicament.

BACKGROUND OF THE INVENTION

A variety of diseases exists that require regular treatment by injectionof a medicament. Such injection can be performed by using injectiondevices, which are applied either by medical personnel or by patientsthemselves. As an example, type-1 and type-2 diabetes can be treated bypatients themselves by injection of insulin doses, for example once orseveral times per day. For instance, a pre-filled disposable insulin pencan be used as an injection device. Alternatively, a re-usable pen maybe used. A re-usable pen allows replacement of an empty medicamentcartridge by a new one. Either pen may come with a set of one-wayneedles that are replaced before each use. The insulin dose to beinjected can then for instance be manually selected at the insulin penby turning a dosage knob and observing the actual dose from a dosewindow or display of the insulin pen. The dose is then injected byinserting the needle into a suited skin portion and pressing aninjection button of the insulin pen.

To be able to monitor insulin injection, for instance to prevent falsehandling of the insulin pen or to keep track of the doses alreadyapplied, it is desirable to measure information related to a conditionand/or use of the injection device, such as for instance information onthe injected insulin type and dose.

In this respect, international patent publication WO 2009/024562discloses a medical device with a value sensor. A Radio FrequencyIdentification (RFID) unit comprises a value sensor such as a pressuresensor and is integrated with a liquid medicament container to enablewireless pressure or other medicament relevant parameter valuemonitoring. The liquid medicament container is coupled with a firsthousing part of the medical device, which first housing part may forinstance constitute a pre-filled disposable injection device. The RFIDunit communicates wirelessly with a control circuit that is contained ina second housing part of the medical device that is releasably attachedto the first housing part. The control circuit is adapted to process thevalues measured by the RFID unit, to compare it with pre-defined valuesand to provide an alert to the user if the measured values fall outsidenormal operating conditions, and to communicate data relating to themeasured values to an external device for further data processing.

The control circuit of the medical device described in WO 2009/024562can thus be used with a series of pre-filled disposable injectiondevices, but the requirement that the RFID unit with the value sensor iscontained in the medicament container of the pre-filled disposableinjection devices significantly increases the costs of the pre-filleddisposable injection device.

SUMMARY OF SOME EMBODIMENTS OF THE INVENTION

It is thus inter alia an object of the present invention to provide anapparatus, a method and a computer program for determining informationrelated to a condition and/or use of a medical device while dispensingwith costly measurement components within the medical device.

According to a first aspect of the present invention, an apparatus isdisclosed, comprising a mating unit for releasably attaching theapparatus to a medical device or for releasably receiving at least apart of the medical device, and one or more optical sensors and/or oneor more acoustical sensors for determining information related to acondition and/or use of the medical device.

According to a second aspect of the present invention, a system isdisclosed, comprising a medical device and an apparatus according to thefirst aspect of the present invention.

According to a third aspect of the present invention, a method isdisclosed, comprising determining, based on information captured by oneor more optical sensors and/or one or more acoustical sensors,information related to a condition and/or use of a medical device,wherein the sensors are comprised in an apparatus that further comprisesa mating unit for releasably attaching the apparatus to the medicaldevice or for releasably receiving at least a part of the medicaldevice.

Accordingly, also an apparatus configured to perform the methodaccording to the third aspect of the present invention shall beconsidered to be disclosed.

According to a fourth aspect of the present invention, furthermore acomputer program is disclosed, comprising program code for performingthe method according to the third aspect of the present invention whenthe computer program is executed on a processor. The computer programmay for instance be storable or encodable in a computer-readable medium.The computer program may for instance at least partially representsoftware and/or firmware of the processor.

According to a fifth aspect of the present invention, furthermore acomputer-readable medium is disclosed, having a computer programaccording to the fourth aspect of the present invention stored thereon.The computer-readable medium may for instance be embodied as anelectric, magnetic, electro-magnetic, optic or other storage medium, andmay either be a removable medium or a medium that is fixedly installedin an apparatus or device. Non-limiting examples of such acomputer-readable medium are a Random-Access Memory (RAM) or a Read-OnlyMemory (ROM). The computer-readable medium may for instance be atangible medium, for instance a tangible storage medium. Acomputer-readable medium is understood to be readable by a computer,such as for instance a processor.

In the following, features and embodiments (exhibiting further features)of the present invention will be described, which are understood toequally apply to the apparatus, system, method, computer program andcomputer-readable medium of the present invention described above. Inparticular, a mentioning that a component is configured or arranged toperform a certain action should be understood to also disclose anaccording method step of the method according to the third aspect of thepresent invention and an according program code of the computer programaccording to the fourth aspect of the present invention. These singlefeatures/embodiments are considered to be exemplary and non-limiting,and to be respectively combinable independently from other disclosedfeatures/embodiments with the apparatus, system, method, computerprogram and computer-readable medium of the present invention asdescribed above. Nevertheless, these features/embodiments shall also beconsidered to be disclosed in all possible combinations with each otherand with the apparatus, system, method, computer program andcomputer-readable medium of the present invention as described above.

The medical device may for instance be configured to eject a medicament(non-limiting examples of a medicament, also frequently referred to as a“drug”, are a substance that, when absorbed into the body of a livingorganism, alters normal bodily function, and a substance used in thetreatment, cure, prevention, or diagnosis of disease or used tootherwise enhance physical or mental well-being of a creature). Theejected drug or medicament may for instance be in a solid (e.g. apowder), liquid or gaseous state, or may comprise a mixture ofcomponents in solid, liquid and/or gaseous states, such as an aerosol.

The ejected medicament may for instance be at least partially (forinstance completely) administered (for instance by way of injection orinfusion) into material, e.g. a body of a creature (for instance a humanbeing or an animal). Non-limiting examples of the medical device arethus an injection device (such as an injection pen) or an infusiondevice (such as an infusion pump). Therein, an injection process may forinstance be differentiated from an infusion process inter alia based onthe time each process takes (For instance, an injection process may havea significantly smaller duration (e.g. less than 5 minutes) as comparedto an infusion process). The administering of the medicament may forinstance be executed with the medical device by an entity (a human beingor a machine). The human being executing the administering of themedicament may then for instance be a patient receiving the medicament,or another person, such as a member of health personnel, such as doctoror a nurse. An example of a medicament to be administered with themedical device is insulin.

The medical device may for instance be a disposable device that isdesigned for a limited number of ejection processes and subsequentdisposal. The medical device may for instance be pre-filled andnon-refillable, so that it has to be disposed after all of orsubstantially all of the medicament(s) contained therein has beeninjected. Equally well, the medical device may be equipped withexchangeable containers comprising the medicament to be injected. Themedical device may for instance be a pen-shaped injection device with aninjection needle at one end and an injection button at the other end.

The apparatus may for instance be a supplementary component with amating unit via which the apparatus is releasably attachable to themedical device (for instance to an outer surface thereof), for examplein a way that the attachment can be released later (for instance by apatient that uses the medical device), in particular without causingdamage to the medical device and the apparatus. Non-limiting examples ofsuch a mating unit are components that allow for a form closure, fitclosure, screw coupling or Velcro-like coupling between the apparatusand the medical device. For instance, the mating unit be configured toengage with or at least partially embrace the medical device, forinstance with one or more arms, clips or rings.

Alternatively, the mating unit of the apparatus may allow releasablyreceiving at least a part of the medical device, for example in a waythat the part of the medical device received by the mating unit can beremoved from the mating unit later (for instance by a patient that usesthe medical device), in particular without causing damage to the medicaldevice and the apparatus. Non-limiting examples of such a mating unitare a recess or opening of the apparatus into which the medical devicecan at least partially be inserted or placed.

In both cases, the mating unit may be configured so that the apparatuscan be attached to or receive only one type of medical device whileexcluding other types of medical devices (for instance by providingprotrusions on the mating unit that have to engage with correspondingrecesses of the medical device or vice versa, with the location of therecesses/protrusions being different for different medical devices), orin such a way that the apparatus can be attached to or receive varioustypes of medical devices.

The apparatus comprises one or more optical/acoustical sensors fordetermining information related to a condition and/or use of the medicaldevice. The information related to the condition and/or use of themedical device may for instance comprise information related to anejection of a medicament with the medical device.

The condition of the medical device may for instance comprisecharacteristics of the medicament contained in the medical device, suchas for instance the type of the medicament, the amount of medicamentremaining in the medical device and usability of the medicament (e.g.with respect to its expiration date).

The use of the medical device may for instance comprise commissioning orpriming of the medical device (for instance when using the medicaldevice for the first time or after a change of a medicament container),preparation of an administering of the medicament (for instance changinga needle, selecting a dose to be ejected), the ejection/administering(e.g. injection) process itself and/or post-ejection/administering tasks(for instance cleaning and needle removal).

The information related to a condition and/or use of the medical devicemay for instance comprise at least information on the type and/or doseof the medicament that is to be or has been ejected/administered, and/orinformation on whether an ejection/administering of the medicament hastaken place, and/or information on when an ejection/administering of themedicament has taken place.

The sensors are either one or more optical sensors or one or moreacoustical sensors. The apparatus may thus comprise one or more opticalsensors, one or more acoustical sensors, or both one or more opticalsensors and one or more acoustical sensors.

An optical sensor is configured to optically determine informationrelated to a condition and/or use of the medical device. Non-limitingexamples of an optical sensor are a camera unit (with or withoutadditional pattern and/or character recognition capability), e.g. forcapturing an image of an electronic or non-electronic display of themedical device where the selected medicament dose to be ejected isshown, and a photometer for detecting a colour, e.g. of the medicamentor of a container that comprises the medicament.

An acoustical sensor is configured to acoustically determine informationrelated to a condition and/or use of the medical device. Non-limitingexamples of an acoustical sensor are a microphone (with or without sounddifferentiation/recognition capability), e.g. for capturing one or moresounds caused during the use of the medical device.

The information related to the condition and/or use of the medicaldevice may for instance be determined by the optical/acousticalsensor(s) when the apparatus is attached to the medical device or whenthe part of the medical device is received in the apparatus. This mayfor instance improve a quality of the determination of the information,for instance by reducing the amount of measurement noise involved in thedetermination.

According to the present invention, thus information related to acondition and/or use of a medical device is determined byoptical/acoustical sensor(s) that are comprised in an apparatus which isconfigured to be attachable to the medical device or to receive at leasta part of the medical device. It is thus not necessary to have sensorswithin the medical device (for instance in a medicament containerthereof) that wirelessly communicate with components outside the medicaldevice. The solution according to the present invention is based on theinsight that a plurality of parameters related to the condition and/oruse of the medical device can be gathered optically and/or acousticallyfrom outside the medical device, i.e. without a need to intrude into themedical device. The apparatus according to the present invention is thusparticularly suited as a supplemental that is attached to the same ordifferent types of off-the-shelf medical devices, for instance medicaldevices that may be pre-filled, disposable, reusable and/or the like.The medical devices may be purely mechanical medical devices, but mayequally comprise electronic components, for instance an electronicdisplay for displaying a medicament dose that has been selected forejection. The information gathered from the medical device by thesensor(s) may then either be further processed by the apparatus (forinstance displayed to a user of the medical device), or communicated toanother device.

According to an embodiment of the present invention, the one or moreoptical sensors comprise at least one optical sensor configured tocapture an image of an information-bearing or information-displayingpart of the medical device. The at least one optical sensor may forinstance be a camera unit. The captured image may for instance befurther processed and/or stored by the apparatus, and/or may be providedto another device.

Therein, the apparatus may for instance be configured to recognizecharacters from the captured image. This may for instance be achieved byOptical Character Recognition (OCR). Then for instance only therecognized characters may be further processed (for instance stored) bythe apparatus, or be provided to another device. The determining of theinformation related to a condition and/or use of the medical devicecomprises recognizing characters from the captured image. Accordingly,the determined information may for instance relate and/or correspond tothe recognized characters (e.g. the determined information at leastpartially equals or comprises the recognized characters such as numbersrepresenting a dose that is to be ejected/administered with the medicaldevice).

The information-displaying part may for instance be a display via whichthe medical device indicates a medicament dose that is to be or has beenejected/administered with the medical device. The display may forinstance be formed by an opening or transparent part in a housing of themedical device through which dose numbers on a sleeve within the medicaldevice can be viewed, wherein the sleeve is coupled to an ejectionmechanism of the medical device. A dose may then for instance beselected by turning the sleeve with a dose button, and the selected doseis then displayed via the opening or transparent part. As a furtherexample, the display may for instance be an electronic display, such asfor instance a Liquid Crystal Display (LCD), that displays a selecteddose.

The information-bearing part may for instance be a printed, engraved orotherwise provided visible code, which may for instance be indicative ofa type and/or an expiration date of a medicament contained in themedical device. This code may for instance be provided on a containerthat includes the medicament. This code may also be provided on themedical device and may then for instance be indicative of a type and/orexpiration date of the medical device.

According to an embodiment of the present invention, the apparatus isconfigured to capture at least two images of the information-bearing orinformation-displaying part of the medical device and to only recognizecharacters from at least one of the at least two captured images if nochange between the at least two captured images is detected.Alternatively, the apparatus is configured to capture at least twoimages of the information-bearing or information-displaying part of themedical device and to only recognize characters from at least one of theat least two captured images if no change between at least two of the atleast two captured images is detected within a specified period of time.

For instance, the apparatus is configured to only recognize charactersfrom at least one of the at least two captured images if no changebetween the at least two captured images is detected. The at least twocaptured images may for instance be subsequently captured images, forinstance a currently captured image and a previously captured image orseveral previously captured images. Alternatively and/or additionally,the apparatus is configured to only recognize characters from at leastone of the at least two captured images if no change between at leasttwo of the at least two captured images is detected within a specifiedperiod of time. The at least two images of the at least two capturedimages may, for instance, be a currently captured image and a previouslycaptured image that was captured immediately before the current imagewas captured or a previously captured image that was captured after orwhen the last change between captured images was detected. Also, theapparatus may for instance be configured to only (or additionally)recognize characters from at least one of the captured images if achange between (at least two of) the at least two captured images isdetected. Therein, detection of the change may not be based on characterrecognition. Furthermore, it may for instance be also determined whetheror not there is a change in the determined information (e.g. in aspecified period of time).

For instance, the currently captured image may be compared to thepreviously captured image(s) in order to determine or detect (e.g. basedon a threshold) whether or not there is a change between the capturedimages. Therein, the comparison to previously captured images may belimited to the image of the previously captured images that was capturedimmediately before the current image was captured and/or to the imagesof the previously captured images that were captured within a firstspecified (e.g. pre-defined) period of time (e.g. 0.1 seconds) beforethe current image was captured. For instance, it is monitored (e.g. byperforming a time measurement) for how long no change between acurrently captured image and a previously captured image is detected.For instance, the currently captured image may be compared to thepreviously captured images that was captured immediately before thecurrent image was captured and, if, for instance, no change is detected,a new time measurement may be started or an already started timemeasurement may be maintained, whereas, if, for instance, a change isdetected, no time measurement may be started and an already started timemeasurement may be stopped. Alternatively, for instance, the currentlycaptured image may be compared to the previously captured image that wascaptured after or when the last change was detected and, if, forinstance, a change is detected, a new time measurement may be startedand an already started time measurement may be stopped, whereas, if, forinstance, no change is detected, an already started time measurement maybe maintained.

The comparison may be based on image analysis techniques such as patternrecognition performed on the currently captured image and on thepreviously captured image(s). For instance, it may be analyzed whether apattern (such as a scale) of the information-bearing orinformation-displaying part of the medical device shown on the currentlycaptured image is changed. For instance, it may be searched for patternsin the image(s) that have a certain size and/or aspect ratio and thesepatterns may be compared with previously saved patterns. In someembodiments, a change may be detected if there is any change between theimages, however, in other embodiments, a change may only be detected ifat least a specified percentage (e.g. a percentage within 5-50%) of theimage between the images changed.

For instance, the captured images are only sub-images of theinformation-bearing or information-displaying part of the medicaldevice. The sub-images may have a low resolution and/or only show a part(such as only a scale and/or characters) of the information-bearing orinformation-displaying part of the medical device. Alternatively, thecaptured sub-images may show the entire information-bearing orinformation-displaying part of the medical device.

For instance, an image of the (entire) information-bearing orinformation-displaying part of the medical device and/or with a highresolution is only captured to perform a character recognition, if nochange between the sub-images is detected (e.g. in the first specifiedperiod of time). This is particularly advantageous to reduce the amountof data to be analyzed.

For instance, during a dose dialling procedure the selected dose to beejected/injected by the medical device displayed on theinformation-bearing or information-displaying part of the medical devicemay permanently change (e.g. interruptions typically (with a highprobability) last less than 0.1 seconds), whereas only the finallyselected dose has to be determined. Thus, it is advantageous to onlyperform the character recognition (and to determine the selected dose)if no change between the previously captured images (e.g. sub-images) isdetected within the first specified period of time.

According to an embodiment of the present invention the determiningfurther comprises at least partially monitoring a timing of anapplication sequence of the medical device.

For instance, the application sequence of the medical device may atleast partially be predefined (e.g. the application sequence maycomprise mandatory and/or optional steps in a predefined sequence). Thesteps of the application sequence may for instance be user actions,which have to be performed on the medical device by a user. Exemplarysteps of the application sequence of a medical device for ejecting amedicament are:

-   -   performing a safety test such as a priming step,    -   dialling/selecting a dose for a medicament that is to be        injected/ejected by the medical device,    -   correcting the dialled/selected dose, and/or    -   injecting/ejecting the dialled/selected dose.

The at least partially monitoring of the timing of the application mayfor instance comprise monitoring (e.g. measuring) the time difference(s)between different steps of an application sequence of the medicaldevice. For instance, the time difference between the end time of a stepof the application sequence and the current time or the start time of asubsequent step of the application sequence may be monitored (e.g.measured). Also, the time difference between the start time and the endtime of a step of the application sequence may for instance be monitored(e.g. measured).

The at least partially monitored timing of the application sequence maythen, for instance, at least partially be compared with one or morespecified periods of time (e.g. the first specified period of time). Forinstance, the time difference between the end time of dialling a dose(e.g. the last time a dialled dose was changed/a dosage knob was turned)and the current time is monitored and compared to the first specifiedperiod of time (e.g. 0.1 seconds). For instance, it is monitored for howlong no change between captured images (e.g. subsequently capturedimages) of the information-bearing or information-displaying part of themedical device is detected. If this monitored time difference, forinstance, exceeds the first specified period of time, the characterrecognition may be performed.

For instance, the monitored timing of the application sequenceadvantageously allows differentiating (e.g. with a high probability)between an interruption (i.e. a pause) of a step of the applicationsequence and a termination of a step of the application sequence and/orbetween two steps of the application sequence such as an ejection duringa priming step and an (e.g. longer lasting) ejection during an injectionstep.

According to an embodiment of the present invention, the apparatus isconfigured to only determine the information and/or to further processthe determined information if the monitored timing at least partiallycorresponds to a specified (e.g. pre-defined) timing of an applicationsequence of the medical device. For instance, it is monitored for howlong no change between subsequently recognized characters (e.g.subsequently recognized from subsequently captured images) is detected.If this monitored time difference, for instance, exceeds a secondspecified (e.g. pre-defined) period of time, the currently recognizedcharacter may, for instance, at least partially be determined tocorrespond to the information related to a condition and/or use of themedical device and/or the determined information may be furtherprocessed by the apparatus. Thus, the monitored timing may, forinstance, confirm (e.g. with a high probability) that a recognizedcharacter at least partially corresponds to the information related to acondition and/or use of the medical device. The second specified periodof time may be greater, equal or smaller than the first specified periodof time.

The recognized character(s) may, for instance, correspond to a selecteddose of a medicament that is to be ejected/injected by the medicaldevice and displayed on the information-bearing orinformation-displaying part of the medical device. For instance,corrections of a selected dose are typically (with a high probability)performed within a second specified period of time (e.g. 3 seconds)after the dose has been dialled. Thus, for instance, the time differencebetween the end time of dialling a dose (e.g. the last time a dialleddose was changed/a dosage knob was turned) and the current time ismonitored and compared to the second specified period of time (3seconds). If the time difference exceeds the second specified period oftime, the recognized character corresponds to the selected dose with ahigh probability.

Additionally, a user confirmation of the determined information may, forinstance, be necessary, for instance to guarantee a correctdetermination thereof. According to an embodiment of the presentinvention, the one or more optical sensors may comprise at least oneoptical sensor configured to capture information representative of acolour of at least a part of the medical device or to determine a colourof at least a part of the medical device. The at least one opticalsensor may for instance be a photometer, for instance a spectralphotometer. Alternatively, the optical sensor may for instance be acamera unit, for instance the same camera unit that is used forcapturing the image of the information-bearing or information-displayingpart of the medical device. The captured information representative ofthe colour or the determined colour may for instance be furtherprocessed and/or stored by the apparatus, and/or may be provided toanother device.

In case that the at least one optical sensor is configured to capturethe information representative of the colour of at least a part of themedical device, the apparatus may for instance be configured torecognize a colour of the part of the medical device from the capturedinformation. The colour recognition may for instance be based on arecognition of grey patterns in a monochrome black-white-picture(wherein different grey patterns may for instance be associated withdifferent colours to be recognized).

According to an embodiment of the present invention, the one or moreacoustical sensors may comprise at least one acoustical sensorconfigured to capture a sound produced when the medical device is used.The sound may for instance be produced by the medical device (or partthereof) mechanically, for instance when components of the medicaldevice are moved with respect to each other (e.g. a clicking sound), butthe sound may also be produced by the medical device electronically, forinstance to indicate a certain status of the medical device (e.g. thatthe medicament ejection/administering is finished or that the medicaldevice is ready for the ejection/administering).

Therein, the apparatus may for instance be configured to differentiateat least two different sounds produced by the device. For instance, asound produced when dialling a dose may be differentiated from a soundproduced when a medicament dose is ejected. Furthermore, an ejectionsound produced when performing a prime shot (without injecting themedicament into a creature) may be differentiated acoustically from anejection sound produced when an actual injection into a creature isperformed.

Therein, the apparatus may for instance be configured to recognize, fromthe captured sound, at least an ejection of a medicament performed withthe medical device. Recognition of the ejection of the medicament mayfor instance trigger the apparatus to perform an action, for instance tocapture an image of an information-bearing or information-displayingpart of the medical device, based on which image then for instance thedose of the ejected medicament may be determined, or to store, processand/or transmit a captured image of an information-bearing orinformation-displaying part of the medical device or informationrelating to such a captured image. This captured image may for instancebe the last image that was captured (in a regular or irregular series ofimage captures) before the ejection of the medicament. This recognitionmay also or alternatively trigger transmission of information capturedby the optical/acoustical sensors to another device.

According to an embodiment of the present invention, the apparatus isconfigured to only capture an image of the information-bearing orinformation-displaying part of the medical device and/or to perform therecognizing characters if the captured sound corresponds to a soundproduced when a dose for a medicament to be ejected by the medicaldevice is dialled. The sound may for instance be a sound producedmechanically such as a clicking sound and/or a sound producedelectronically. Alternatively and/or additionally, the apparatus may forinstance be configured to capture a picture at least partiallyindependently of a captured sound (e.g. at least one picture perspecified time interval). Furthermore, it may for instance be alsodetermined whether or not there is a change in the determinedinformation (e.g. in a specified period of time).

The information related to a condition and/or use of the medical devicemay for instance be determined by capturing an image of aninformation-bearing or information-displaying part of the medical deviceas described above. The captured image may for instance be furtherprocessed and/or stored by the apparatus, and/or may be provided toanother device. Therein, the apparatus may for instance be configured torecognize characters from the captured image.

This embodiment may be advantageous, because real-time detection of asound produced when the medical device may be used is less energyconsuming than, for instance, permanently capturing an image to detect achange in the captured image(s), for instance showing aninformation-bearing or information-displaying part of the medicaldevice.

According to an embodiment of the present invention, the apparatus mayfurther comprise a display unit for displaying informationrepresentative of at least a part of the determined information (e.g.information on a dose of the medicament that is to be or has beenselected). The display unit may for instance be an electronic displaysuch as a Liquid Crystal Display (LCD), an Organic Light Emitting Diode(OLED) display, and/or the like. In an example embodiment, theinformation shown on the display unit may continuously be updated toshow the currently selected dose during dose dialling. The display unitmay further show the ejected dose after ejection. The display unit mayshow additional information, for example a current time, the time sincethe last ejection/administering, and/or the like. The display unit mayfor instance be advantageous since a display of the medical device (e.g.a display via which the dose of the medicament that is to be or has beenejected is indicated) may at least partially be covered by one or moreoptical sensors of the apparatus, so that it may be advantageous toprovide optical feedback to the user via the display unit when the userdials a dose.

According to an embodiment of the present invention, the apparatus mayfurther comprise an interface configured to provide the determinedinformation to another device via a wired or wireless connection. Theinterface may for instance be a standardized interface such as forinstance a Universal Serial Bus (USB) or a Bluetooth interface, but mayequally well be a proprietary interface. The wireless connection may forinstance be based on radio waves, optical waves, sound waves, but alsoon magnetic or electric fields.

Therein, the other device receiving the information may for instance beconfigured to store the information, for instance in the form of alogbook or archive, and/or to use the information to monitor use of themedical device (for instance to launch an alert if improper handling ofthe medical device is detected), and/or to use the information (andpotentially further information) to determine a proposal of the nexttype and/or dose of medicament to be administered. In an exampleembodiment, such information may be provided back to the medical deviceand may optionally be displayed to a user of the medical device.

The other device may for instance be a blood glucose monitoring system,which may for instance reveal individual patterns of blood glucosechanges and may help in the planning of meals, activities, and at whattime of day to take medicaments or to administer a medicament.

The blood glucose monitoring system may for instance comprise a bloodglucose meter for measuring the blood glucose level of the patient thatuses the medical device, or may (for instance regularly or irregularly)receive information on this blood glucose level from a blood glucosemeter. The blood glucose meter may for instance measure the bloodglucose level based on a drop of blood placed on a disposable test stripwhich interfaces with a digital meter.

Provision of the information determined by the one or more sensors ofthe apparatus may be triggered by a user (e.g. by pushing a button) orautomatically, for instance in response to a detection that a medicamentdose is or has been ejected.

According to an embodiment of the present invention, the apparatus mayfurther comprise an interface configured to receive informationindicative of a type and/or dose of medicament to be ejected. Suchinformation may for instance be received from a monitoring system, suchas for instance a blood glucose monitoring system as described above.

Therein, the apparatus may then for instance further comprise a displayunit for displaying the received information indicative of the typeand/or dose of medicament to be ejected. This display unit may forinstance be the same display on which the information determined by theoptical/acoustical sensor(s) of the apparatus are displayed, or anotherdisplay unit.

Therein, the apparatus may for instance further comprise a controllerfor controlling if a type and/or dose of medicament selected forejection at the medical device matches the type and/or dose ofmedicament to be ejected as indicated by the received information. Thiscontributes to avoid application of inaccurate doses. For instance, if amismatch is detected, a warning or alert signal may be issued by theapparatus.

According to an embodiment of the present invention, the apparatus mayfurther comprise a processor for determining a proposal of a type and/ordose of medicament to be ejected (for instance ejected to be injectedinto a creature). This proposal may for instance at least be based oninformation on at least one previously ejected medicament dose, which isstored in the apparatus. The proposal may for instance further be basedon one or more parameters (e.g. a blood glucose level) measured from acreature (e.g. a patient) that is to receive the medicament (e.g. viainjection or infusion). Information representative of the one or moreparameters may for instance be received via a user interface of theapparatus (for instance entered by the user of the medical device), ormeasured by the apparatus (for instance by a blood glucose metercomprised in or connected to the apparatus), or received via aninterface (e.g. by means of a wired or wireless connection).

The apparatus may then for instance implement or comprise a bloodglucose monitoring system.

According to an embodiment of the present invention, the apparatus mayfurther comprise a measurement unit for measuring at least one parameterthat is representative of a condition of a creature (e.g. a patient)that is to receive a medicament ejectable by the medical device. The atleast one parameter may for instance be relevant for determining a typeand/or dose of the medicament to be received by the creature.

The at least one parameter may for instance be a blood glucose level.The measurement unit may then for instance be a blood glucose meter, andmay for instance comprise an opening for receiving a carrier (e.g. astrip) with a drop of blood of the creature.

According to an embodiment of the present invention, the apparatus mayfurther comprise an acoustical signal generator for producing acousticalsignals related to the condition and/or use of the medical device. Saidacoustical signal generator may for instance be embodied as aloudspeaker or buzzer. It may for instance produce a feedback and/orwarning signal.

According to an embodiment of the present invention, a user of themedical device is required to comfim said determined information (e.b.by performing a confirming action, such as for instance pressing abutton of the apparatus). For instance, the determined information isonly stored and/or further processed if the user confirms the determinedinformation as correct. Otherwise, the determined information may becorrected (e.g. by the user) and the corrected determined informationmay then be stored and/or further processed. If the determined isneither comfirmed nor corrected it may, for instance, be discarded.

Only a confirmation by a user may be versatile enough to cover manypossible actions of the user during an application sequence and to avoidthe storage/further processing of incorrectly determined information.

According to an embodiment of the present invention, the apparatus isconfigured to determine the information at least partially fromrecognized characters (e.g. characters recognized from at least oneimage captured from the information-bearing or information-displayingpart of the medical device). Accordingly, the determined information mayfor instance relate and/or correspond to the recognized characters (e.g.the determined information at least partially equals or comprises therecognized characters such as numbers representing a dose that is to beejected/administered with the medical device). This may, for instance,advantageously allow to reduce the amount of data corresponding to (e.g.representing) the determined information.

According to an embodiment of the third aspect of the present invention,the method further comprises receiving the information captured by theone or more optical sensors and/or the one or more acoustical sensors.Said optical/acoustical sensors and a unit that performs the determiningmay for instance be different components of an apparatus, but mayequally well at least partially be performed by the same component orcomponents of an apparatus.

According to an embodiment of the third aspect of the present invention,the method further comprises displaying information representative of atleast a part of the information related to the a condition and/or use ofthe medical device.

According to an embodiment of the third aspect of the present invention,the method further comprises providing information representative of atleast a part of the information related to the condition and/or use ofthe medical device to another device via a wired or wireless connection.

According to an embodiment of the third aspect of the present invention,the one or more optical sensors comprise at least one optical sensorconfigured to capture an image of an information-bearing orinformation-displaying part of the medical device.

Said determining may then for instance comprise recognizing charactersfrom the captured image.

According to an embodiment of the third aspect of the present invention,the one or more optical sensors comprise at least one optical sensorconfigured to capture information representative of a colour of at leasta part of the medical device or to determine a colour of at least a partof the medical device.

Said determining may then for instance comprise recognizing a colourfrom the captured information.

According to an embodiment of the third aspect of the present invention,the one or more acoustical sensors comprise at least one acousticalsensor configured to capture a sound produced when the medical device isused.

Said determining may then for instance comprise recognizing, from thecaptured sound, at least an ejection of a medicament performed with themedical device.

These and further concepts of the invention will be apparent from andelucidated with reference to the detailed description presentedhereinafter.

BRIEF DESCRIPTION OF THE FIGURES

In the figures show:

FIG. 1: An exploded view of an injection device;

FIG. 2a : a schematic illustration of a supplementary device to bereleasably attached to the injection device of FIG. 1 according to anembodiment of the present invention;

FIG. 2b : a schematic illustration of a supplementary device configuredto at least partially receive the injection device of FIG. 1 accordingto an embodiment of the present invention;

FIG. 3a : a distribution of functions among devices according to anembodiment of the present invention;

FIG. 3b : a further distribution of functions among devices according toan embodiment of the present invention;

FIG. 3c : a further distribution of functions among devices according toan embodiment of the present invention;

FIG. 3d : a further distribution of functions among devices according toan embodiment of the present invention;

FIG. 4: a schematic view of the supplementary device of FIG. 2a in astate where it is attached to the injection device of FIG. 1;

FIG. 5a : a flowchart of an embodiment of a method according to thepresent invention;

FIG. 5b : a flowchart of a further embodiment of a method according tothe present invention;

FIG. 5c : a flowchart of a further embodiment of a method according tothe present invention;

FIG. 5d : a typical application sequence of the injection device of FIG.1;

FIG. 5e : a flowchart of a further embodiment of a method according tothe present invention;

FIG. 5f : a flowchart of a further embodiment of a method according tothe present invention;

FIG. 5g : a flowchart of a further embodiment of a method according tothe present invention;

FIG. 6: a schematic illustration of a tangible storage medium 60according to an embodiment of the present invention; and

FIG. 7: an information sequence chart that illustrates an informationflow between various devices according to an embodiment of the presentinvention.

DETAILED DESCRIPTION OF SOME EMBODIMENTS OF THE INVENTION

In the following, embodiments of the present invention will be describedwith reference to an insulin injection device. The present invention ishowever not limited to such application and may equally well be deployedwith injection devices that eject other medicaments, or with other typesof medical devices.

FIG. 1 is an exploded view of an injection device 1, which may forinstance represent Applicant's Solostar® insulin injection pen.

Injection device 1 of FIG. 1 is a pre-filled, disposable injection penthat comprises a housing 10 and contains an insulin container 14, towhich a needle 15 can be affixed. The needle is protected by an innerneedle cap 16 and an outer needle cap 17, which in turn can be coveredby a cap 18.

An insulin dose to be ejected from injection device 1 can be selected byturning the dosage knob 12, and the selected dose is then displayed viadosage window 13, for instance in multiples of so-called InternationalUnits (IU), wherein one IU is the biological equivalent of about 45.5 μgpure crystalline insulin (1/22 mg). An example of a selected dosedisplayed in dosage window 13 may for instance be 30 IUs, as shown inFIG. 1. It should be noted that the selected dose may equally well bedisplayed differently, for instance by means of an electronic display.

Turning the dosage knob 12 causes a mechanical click sound to provideacoustical feedback to a user. The numbers displayed in dosage window 13are printed on a sleeve that is contained in housing 10 and mechanicallyinteracts with a piston in insulin container 14. When needle 15 is stuckinto a skin portion of a patient, and then injection button 11 ispushed, the insulin dose displayed in display window 13 will be ejectedfrom injection device 1. When the needle 15 of injection device 1remains for a certain time in the skin portion after the injectionbutton 11 is pushed, a high percentage of the dose is actually injectedinto the patient's body. Ejection of the insulin dose also causes amechanical click sound, which is however different from the soundsproduced when using dosage knob 12.

Injection device 1 may be used for several injection processes untileither insulin container 14 is empty or the expiration date of injectiondevice 1 (e.g. 28 days after the first use) is reached.

Furthermore, before using injection device 1 for the first time, it maybe necessary to perform a so-called “prime shot” to remove air frominsulin container 14 and needle 15, for instance by selecting two unitsof insulin and pressing injection button 11 while holding injectiondevice 1 with the needle 15 upwards.

For simplicity of presentation, in the following, it will be exemplarilyassumed that the ejected doses substantially correspond to the injecteddoses, so that, for instance when making a proposal for a dose to beinjected next, this dose equals the dose that has to ejected by theinjection device. Nevertheless, differences (e.g. losses) between theejected doses and the injected doses may of course be taken intoaccount.

FIG. 2a is a schematic illustration of an embodiment of a supplementarydevice 2 to be releasably attached to injection device 1 of FIG. 1.Supplementary device 2 comprises a housing 20 with two clips 20-1 and20-2 that function as a mating unit configured and embrace the housing10 of injection device 1 of FIG. 1, so that supplementary device 2 sitstightly on housing 10 of injection device 1, but is neverthelessremovable from injection device 1, for instance when injection device 1is empty and has to be replaced. Alternatively, the clips 20-1 and 20-2may for instance be replaced by a ring-shaped member, into which theupper portion of housing 10 of injection device 10 may be inserted sothat a tight fit of supplementary device 2 on housing 10 of injectiondevice 1 is achieved. Supplementary device 2 contains optical andacoustical sensors for gathering information from injection device 1. Atleast a part of this information, for instance a selected dose (andoptionally a unit of this dose), is displayed via display unit 21 ofsupplementary device 2, which accounts for the fact that dosage window13 of injection device 1 may at least partially be obstructed bysupplementary device 2 when being attached to injection device 1.Supplementary device 2 further comprises a button 22, for instance toturn on/off supplementary device 2, and/or to trigger actions (forinstance to cause establishment of a connection to another device,and/or to trigger transmission of information from supplementary device2 to another device, e.g. a blood glucose monitoring system, and/or tocause calculation of a next dose). As will be explained in more detailbelow, the functionality of such a blood glucose monitoring systemand/or the functionality of a blood glucose meter may also be providedby supplementary device 2.

FIG. 2b shows an alternative embodiment of a supplementary device 3 thatis configured to at least partially receive the injection device 1 ofFIG. 1. Supplementary device 3 comprises a lower part 30-1 and an upperpart 30-2 that are connected to each other via hinges so that lower part30-1 and upper part 30-2 can be collapsed to form a case.

Lower part 30-1 comprises a mating unit that is formed as a recess 31and is configured to receive injection device 1. When injection device 1is placed into recess 31, optical and/or acoustical sensors comprised insupplementary device 3 can gather information from injection device 1.At least a part of this information, for instance a selected dose, canbe displayed via display unit 32 of supplementary device 3. A use caseof supplementary device 3 may for instance be that a user (which may bethe patient receiving that is to receive the injection or anotherperson) of injection device 1 selects a dose by turning dosage knob 12of injection device 1 and then, before performing the injection, placesinjection device 1 into recess 31 of supplementary device 3. Afteroptical recognition of the selected dose, which may for instance beindicated by displaying the dose on display 32 and/or producing anelectronic sound on an acoustical signal generator, the user may thenremove injection device 1 from the recess 31 and perform the actualinjection. A click sound caused by injection device 1 when the ejection(which in the exemplary case of the medical device being an injectionpen coincides with the injection) is performed may also be sensed by anacoustical sensor of supplementary device 3 and may serve as anacknowledgement that the recognized dose has actually beenejected/injected. After the ejection/injection has been performed, theinjection device 1 can be stored in recess 31 of supplementary device 3.Supplementary device 3 may thus also serve as storage container forinjection device 1, and may be configured accordingly to ensure thatquality of the injection device 1 and the insulin contained therein doesnot deteriorate even when supplementary device 3 is carried around.

Supplementary device 3 also comprises a button 34, for instance to turnon/off supplementary device 3, and/or to trigger actions (for instanceto cause transmission of information from supplementary device 2 toanother device, e.g. a blood glucose monitoring system, or to causecalculation of a next dose).

In FIG. 2b , furthermore an optional slot 33 is shown, via whichsupplementary device 3 may receive carrier material (e.g. strips) withdrops of blood, which may then be processed by an optional blood glucosemeter in order to determine a current blood glucose level of a patient.

Supplementary device 3 may furthermore implement functionality of ablood glucose monitoring system.

FIGS. 3a-3d show various possible distributions of functions amongdevices when using a supplementary device (such as the supplementarydevices of FIGS. 2a and 2b ) together with an injection device.

In constellation 4 of FIG. 3a , the supplementary device 41 (such as thesupplementary devices of FIGS. 2a and 2b ) determines information frominjection device 40, and provides this information (e.g. type and/ordose of the medicament to be injected) to a blood glucose monitoringsystem 42 (e.g. via a wired or wireless connection).

Blood glucose monitoring system 42 (which may for instance be embodiedas computer, personal digital assistant or mobile phone) keeps a recordof the injections a patient has received so far (based on the ejecteddoses, for instance by assuming that the ejected doses and the injecteddoses are the same, or by determining the injected doses based on theejected doses, for instance be assuming that a pre-defined percentage ofthe ejected dose is not completely received by the patient), and may forinstance propose a type and/or dose of insulin for the next injectionfor this patient. This proposal may be based on information on one ormore past injections received by the patient, and on a current bloodglucose level, that is measured by blood glucose meter 43 and provided(e.g. via a wired or wireless connection) to blood glucose monitoringsystem 42.

Therein, blood glucose meter 43 may be embodied as a separate devicethat is configured to receive a small blood probe (for instance on acarrier material) of a patient and to determine the blood glucose levelof the patient based on this blood probe. Blood glucose meter 43 mayhowever also be a device that is at least temporarily implanted into thepatient, for instance in the patient's eye or beneath the skin.

The proposed type and/or dose of insulin may be provided from bloodglucose monitoring system 42 to supplementary device 41, where it mayfor instance be displayed to the user of injection device 40 and/or usedto check if it matches a dose that is then injected into the patient.Mismatches may for instance trigger warning or alarm signals.

FIG. 3b is a modified constellation 4′ where the blood glucose meter 43of FIG. 3a has been included into blood glucose monitoring system 42 ofFIG. 3a , thus yielding the modified blood glucose monitoring system 42′of FIG. 3b . The functionality of injection device 40 and 41 of FIG. 3ais not affected by this modification. Also the functionality of bloodglucose monitoring system 42 and blood glucose meter 43 combined intoblood glucose monitoring system 42′ are basically unchanged, apart fromthe fact that both are now comprised in the same device, so that wiredor wireless communication between these devices is no longer necessary.However, communication between blood glucose monitoring system 42 andblood glucose meter 43 takes place within system 42′.

FIG. 3c is another modified constellation 4″, where the functionality ofthe blood glucose monitoring system 42 of FIG. 3a has been included intosupplementary device 41 of FIG. 3a , yielding a modified supplementarydevice 41′. Injection device 40 and blood glucose meter 43 are basicallynot affected by this modification, apart from the fact that bloodglucose meter 43 now communicates with a combined unit 41′.

FIG. 3d shows another modified constellation 4″′, where thefunctionality of the blood glucose monitoring system 42 and of the bloodglucose meter 43 of FIG. 3a has been included into the supplementarydevice 41 of FIG. 3a , thus yielding a modified supplementary device41″. Modified supplementary device 41″ is thus capable of measuring ablood glucose level of a patient, to perform blood glucose monitoring,and to read information from the injection device 40. Modifiedsupplementary device 41″ thus may be understood to comprise asupplementary device part, a blood glucose monitoring part, and a bloodglucose meter part. The blood glucose monitoring part may then use theinformation read from the injection device 1 (by the supplementarydevice part) and measured by the blood glucose meter part. Proposals fornext doses to be taken may then be displayed and/or checked against thedoses actually injected with injection device 1.

FIG. 4 shows a schematic view of the supplementary device 2 of FIG. 2ain a state where it is attached to injection device 1 of FIG. 1.

With the housing 20 of supplementary device 2, a plurality of componentsare comprised, which are controlled by a processor 24, which may forinstance be a microprocessor, a Digital Signal Processor (DSP),Application Specific Integrated Circuit (ASIC), Field Programmable GateArray (FPGA) or the like. Processor 24 executes program code (e.g.software or firmware) stored in a program memory 240, and uses a mainmemory 241, for instance to store intermediate results. Main memory 241may also be used to store a logbook on performed ejections/injectionsand information required to determine a proposal for a nextejection/injection. Program memory 240 may for instance be a Read-OnlyMemory (ROM), and main memory may for instance be a Random Access Memory(RAM).

In an example embodiment, processor 24 interacts with a button 22, viawhich supplementary device 2 may for instance be turned on and off.Button 22 may also be used to trigger further actions, for instance totrigger establishment of a connection to another device, or to trigger atransmission of information to another device, or to acknowledgeinformation presented to a user of supplementary device 2.

Processor 24 controls a display unit 21, which is presently embodied asa Liquid Crystal Display (LCD). Display unit 21 is used to displayinformation to a user of supplementary device 2, for instance on presentsettings of injection device 1, or on a next injection to be given.Display unit 21 may also be embodied as a touch-screen display, forinstance to receive user input.

Processor 24 also controls an optical sensor 25, which is presentlyembodied as an Optical Character Recognition (OCR) reader, that iscapable of capturing images of the dosage window 13, in which acurrently selected dose is displayed (by means of numbers printed on thesleeve 19 contained in injection device 1, which numbers are visiblethrough the dosage window 13). OCR reader 25 is further capable ofrecognizing characters (e.g. numbers) from the captured image and toprovide this information to processor 24. Alternatively, unit 25 insupplementary device 2 may only be an optical sensor for capturingimages and providing information on the captured images to processor 24.Then either processor 24 or a device to which this information istransmitted by supplementary device 2 may be responsible for performingOCR on the captured images. The latter approach may allow reducing thecomplexity of the supplementary device 2.

Optionally, processor 24 also controls light-sources such as lightemitting diodes (LEDs) (e.g. white and/or coloured LEDs), which may beused to illuminate the dosage window 13, in which a currently selecteddose is displayed. Due to light potentially reflecting off the surfaceof a transparent part of the injection device, a diffuser may be used infront of the light-sources, for instance a diffuser made from a piece ofacrylic glass. Furthermore, the optical sensor may optionally comprise alens (e.g. an aspheric lens) leading to a magnification (e.g. amagnification of more than 3:1).

Processor 24 further controls a photometer 26, that is configured todetermine an optical property of the housing 10 of injection device 1,for example a colour or a shading. The optical property may only bepresent in a specific portion of housing 10, for example a colour orcolour coding of sleeve 19 or of an insulin container comprised withininjection device 1, which colour or colour coding may for instance bevisible through a further window in housing 10 (and/or in sleeve 19).Information on this colour is then provided to processor 24, which maythen determine the type of injection device 1 or the type of insulincontained in injection device 1 (e.g. SoloStar Lantus with purple colourand SoloStar Apidra with blue colour). Alternatively, a camera unit maybe used instead of photometer 26, and an image of the housing, sleeve orinsulin container may then be provided to processor 24 to determine thecolour of the housing, sleeve or insulin container by means of imageprocessing. Further, one or more light sources may be provided toimprove reading of OCR reader 25 and/or photometer 26.

The light source may provide light of a certain wavelength or spectrumto improve colour detection by photometer 26. The light source may bearranged in such a way that unwanted reflections, for example by dosagewindow 13, are avoided or reduced.

In an example embodiment, instead of or in addition to photometer 26, acamera unit may be deployed to detect a code (for instance a bar code,which may for instance be a one- or two-dimensional bar code) related tothe injection device and/or the medicament contained therein. This codemay for instance be located on the housing 10 or on a medicamentcontainer contained in injection device 1, to name but a few examples.This code may for instance indicate a type of the injection deviceand/or the medicament, and/or further properties (for instance aexpiration date).

Processor 24 further controls (and/or receives signals from) an acousticsensor 27, which is configured to sense sounds produced by injectiondevice 1. Such sounds may for instance occur when a dose is dialled byturning dosage knob 12 and/or when a dose is ejected/injected bypressing injection button 11, and/or when a prime shot is performed.These actions are mechanically similar but nevertheless sounddifferently (this may also be the case for electronic sounds thatindicate these actions). Either the acoustic sensor 27 and/or processor24 may be configured to differentiate these different sounds, forinstance to be able to safely recognize that an injection has takenplace (rather than a prime shot only). A sound captured by acousticsensor 27 may also be provided to another device that then performs thesound recognition. This may again reduce the complexity of supplementarydevice 2.

Processor 24 further controls an acoustical signal generator 23, whichis configured to produce acoustical signals that may for instance berelated to the operating status of injection device 1, for instance asfeedback to the user. For example, an acoustical signal may be launchedby acoustical signal generator 23 as a reminder for the next dose to beinjected or as a warning signal, for instance in case of misuse.Acoustical signal generator may for instance be embodied as a buzzer orloudspeaker. In addition to or as an alternative to acoustical signalgenerator 23, also a haptic signal generator may be used to providehaptic feedback, for instance by means of vibration.

In an example embodiment, processor 24 controls a wireless unit 28,which is configured to transmit and/or receive information to/fromanother device in a wireless fashion. Such transmission may for instancebe based on radio transmission or optical transmission. Alternatively,wireless unit 28 may be substituted or complemented by a wired unitconfigured to transmit and/or receive information to/from another devicein a wire-bound fashion, for instance via a cable or fibre connection.Such units for wireless or wire-bound transmission/reception may forinstance be dispensed with in scenarios as depicted in FIG. 3d , wheresupplementary device 41′″ implements blood glucose monitoring systemfunctionality and also implements a blood glucose meter. When data istransmitted, the units of the data (values) transferred may beexplicitly or implicitly defined. For instance, in case of an insulindose, always International Units (IU) may be used, or otherwise, theused unit may be transferred explicitly, for instance in coded form.

Finally, supplementary device 2 also comprises an optional blood glucosemeter 29, which is configured to receive a blood probe (e.g. on acarrier such as a strip) of a patient that is to receive an injectionand to determine a blood glucose level therefrom, which then is providedto processor 24 for further processing, for instance to determine aproposal for a type and/or dose of an injection to be applied next.

The supplementary device 2 of FIG. 4 is thus capable of determininginformation related to a condition and/or use of injection device 1.This information may be either processed by supplementary device 2itself, or may at least partially be provided to another device (e.g. ablood glucose monitoring system).

As a further detail, FIG. 4 shows a recess 20-3 formed on the housing 20of supplementary device 2, which recess is configured to receive a key10-3 formed at a specific position on housing 10 of injection device 1,when supplementary device 2 is attached to injection device 1. Thisrecess-key pair may for instance be arranged to ensure thatsupplementary device 2 can only be attached to a specific type ofinjection device 1, for instance to ensure compatibility. Differenttypes of injection devices 1 may for instance use different positions ofkey 10-1 and/or different forms of key 10-1 to ensure that onlycompatible supplementary devices 2 are used. Alternatively, suchkey-recess pairs may be dispensed with, to allow that supplementarydevice 2 can be used with a variety of different injection devices 1.Supplementary device 2 may then for instance be configured to functionwith a broad range of injection devices 1. Specifics of single injectiondevices 1 may nevertheless be taken into account, for instance byrecognizing different types of injection devices 1, for instance basedon codes or colours that are characteristic of the different types ofinjection devices 1. Such codes or colours may be sensed by thesupplementary device 1 optically in a similar fashion as alreadyexplained above, i.e. based on OCR and/or colour recognition (andsubsequent comparison of the recognized values (colours with a table).

It should be noted that the functional components of supplementarydevice 2 as shown in FIG. 4 may equally be present and function in thesame way in supplementary device 3 of FIG. 2 b.

FIGS. 5a-5c are flowcharts of embodiments of methods according to thepresent invention. These methods may for instance be performed byprocessor 24 of supplementary device 2 (see FIGS. 2b and 4), but also bya processor of supplementary device 3 of FIG. 2b , and may for instancebe stored in program memory 240 of supplementary device 2, which may forinstance take the shape of tangible storage medium 60 of FIG. 6.

FIG. 5a shows method steps that are performed in scenarios as shown inFIGS. 3a and 3b , where information read by supplementary device 41 frominjection device 40 is provided to blood glucose monitoring system 42 or42′ without receiving information back from blood glucose monitoringsystem 42 or 42′.

The flowchart 500 starts for instance when the supplementary device isturned on or is otherwise activated.

In a step 501, a type of medicament, for example insulin, provided bythe injection device is determined, for instance based on colourrecognition or based on recognition of a code printed on injectiondevice or a component thereof as already described above. Detection ofthe type of medicament may not be necessary if a patient always takesthe same type of medicament and only uses an injection device with thissingle type of medicament. Furthermore, determination of the type ofmedicament may be ensured otherwise (e.g. by the key-recess pair shownin FIG. 4 that the supplementary device is only useable with onespecific injection device, which may then only provide this single typeof medicament).

In a step 502, a currently selected dose is determined, for instance byOCR of information shown on a dosage window of injection device asdescribed above. This information is then displayed to a user of theinjection device in a step 503, this may however also be optional.

In a step 504, it is checked if an ejection has taken place, forinstance by sound recognition as described above. Therein, a prime shotmay be differentiated from an actual injection (into a creature) eitherbased on respectively different sounds produced by the injection deviceand/or based on the ejected dose (e.g. a small dose, for instance lessthan a pre-defined amount of units, e.g. 4 or 3 units, may be consideredto belong to a prime shot, whereas larger doses are considered to belongto an actual injection).

If an ejection has taken place, the determined data, i.e. the selecteddose and—if applicable—the type of medicament (e.g. insulin), istransmitted to another device, for instance a blood glucose monitoringsystem. If a differentiation has been made concerning the nature of theejection, for instance if the ejection was performed as a prime shot oras an actual injection, this information may also be transmitted.

Otherwise, steps 502 and 503 are repeated.

After transmission of the data, the flowchart 500 terminates.

FIG. 5b shows method steps that are performed in scenarios as shown inFIGS. 3a and 3b , where information read by supplementary device 41 frominjection device 40 is provided to blood glucose monitoring system 42 or42′ and information is also received back from blood glucose monitoringsystem 42 or 42′.

In flowchart 600, in a step 601, information relevant for a nextinjection (e.g. a proposal for a type and/or dose of a medicament (e.g.insulin) to be injected by a patient next) is received at thesupplementary device, for instance from a blood glucose monitoringsystem.

In a step 602, this information is displayed to a user of thesupplementary device, for instance to inform the user on the details ofthe next dose to be injected.

After a type of medicament (e.g. insulin) has been optionally determined(step 603), and also a selected dose has been determined (step 604) anddisplayed (step 605), in a step 606, it is checked if the determinedinformation (selected dose and optionally the type of medicament)matches the information received in step 601. If this is the case, anapproval is displayed in step 608. Otherwise, in step 607 a warning isdisplayed that the selected dose does not yet match the proposed dose.

In step 609, it is then checked if an ejection has been performed, andif this is the case, the determined data is transmitted (e.g. to a bloodglucose monitoring system), for instance with further information on thenature of the ejection (prime shot or actual injection), and otherwise,steps 604-608 are repeated.

Therein, it is noted that steps 603, 604, 605, 609 and 610 of flowchart600 correspond to steps 501-505 of flowchart 500 of FIG. 5a , with theexplanations and examples given there also applying here.

FIG. 5c shows method steps that are performed in scenarios as shown inFIGS. 3c and 3d , where information read by supplementary device 41′ or41″ from injection device 40 is processed by supplementary device 41′ or41″ itself, for instance to perform blood glucose monitoring.

In a step 701 of flowchart 700, information related to a next injection(e.g. type and/or dose of the medicament (e.g. insulin)) is determinedby the supplementary device, for instance based on information on acurrent blood glucose level either determined by the blood glucose metercomprised in the supplementary device itself (see FIG. 3d ) or receivedfrom an external blood glucose meter (see FIG. 3c ).

In a step 702, this information is then displayed via a display unit ofthe supplementary device.

After a type of medicament (e.g. insulin) has been optionally determined(step 703), and also a selected dose has been determined (step 704) anddisplayed (step 705), in a step 706, it is checked if the determinedinformation from steps 703 and 704 (selected dose and optionally thetype of medicament) matches the information determined in step 701. Ifthis is the case, an approval is displayed in step 708. Otherwise, awarning is displayed in step 707 that the selected dose does not yetmatch the proposed dose.

In step 709, it is then checked if an ejection has been performed, andif this is the case, the determined data is stored (for instance in alogbook, for instance as a basis for later blood glucose monitoringprocessing), for instance together with further information on thenature of the ejection (prime shot or actual injection), and otherwise,steps 704-708 are repeated.

Therein, it is noted that steps 703, 704, 705 and 709 of flowchart 700correspond to steps 501-505 of flowchart 500 of FIG. 5a , with theexplanations and examples given there also applying here.

FIG. 5d shows a typical application sequence of injection device 1, forinstance Applicant's Solostar® insulin injection pen.

For injection device 1, a safety test 810 (i.e. priming) is requiredbefore the actual injection procedure 820.

After affixing the needle 15 to the injection device 1 in a step 801,the user is required to select a dose of two units to be ejected byinjection device 1 in a step 811. An insulin dose can be selected byturning dosage knob 12. Step 811 is the first step of the safety test810.

In a step 812, the selected dose is ejected so that normally insulinemerges from the tip of the needle 15 affixed to the injection device 1.

In a step 813, it is determined whether or not the safety test 810 mustbe repeated. The safety test 810 must be repeated if no insulin emergesfrom the tip of the needle in step 812.

Otherwise in a step 821, a dose to be injected by the injection device 1is selected. An insulin dose can be selected by turning dosage knob 12.This is the first step of the actual injection procedure 820.

In a step 822, the needle 15 is injected into the body.

In a step 823, the selected dose is ejected by the injection device 1and injected into the body.

In a step 824, the user waits for about 5 seconds after the actualinjection.

Apparently, the safety test 810 is indistinguishable from the selectionof the dose for the actual injection (see steps 811 and 821) andsuccessive injection (see steps 812 and 823) as the acoustical andoptical signals are identical. If the selected doses determined by thesupplementary device 2 are for instance stored in a logbook, it ishowever useful to distinguish between both situations.

Exemplary time steps of the application sequence of injection device 1(e.g. Applicant's Solostar® insulin injection pen) may be the following:

-   -   Time difference between dose dialing (e.g. turning the dosage        knob) and injection/ejection >3 seconds    -   Time for injection/ejection 1-30 seconds    -   Time difference after the injection/ejection before dosage knob        12 is turned again >3 seconds    -   Time difference after the safety test/priming before dosage knob        12 is turned again again >1 second.

Accordingly, objectives for determining the selected dose are forinstance:

-   -   Dialling the dose/turning the dosage knob is monitored with a        high repetition rate.    -   The time difference between dialling the dose/turning the dosage        knob and displaying the corresponding number is minimized.    -   If the selected dose/the dosage knob remains unchanged for more        than 3 seconds, the corresponding number (e.g. a number visible        through dosage window 13) is used as the number of units        selected for injection.    -   If the selected dose/dosage knob reads zero for more than 0.1        seconds, the number is returned.

FIG. 5e shows in more detail exemplary method steps that are performedwhen the selected dose is determined based on the use of optical sensorsonly. For instance, these steps may be performed in steps 502, 604 and704 of FIGS. 5a -c.

In a step 901, a sub-image is captured by an optical sensor such asoptical sensor 25 of supplementary device 2. The captured sub-image isfor instance an image of at least a part of the dosage window 13 ofinjection device 1, in which a currently selected dose is displayed(e.g. by means of numbers and/or a scale printed on the sleeve 19 ofinjection device 1, which is visible through the dosage window 13). Forinstance, the captured sub-image may have a low resolution and/or onlyshow a part of the part of sleeve 19 which is visible through dosagewindow 13. For instance, the captured sub-image either shows the numbersor the scale printed on the part of sleeve 19 of injection device 1which is visible through dosage window 13.

After capturing an image, it is, for instance, further processed asfollows:

-   -   Division by a previously captured background image;    -   Binning of the image(s) to reduce the number of pixels for        further evaluations;    -   Normalization of the image(s) to reduce intensity variations in        the illumination;    -   Sheering of the image(s); and/or    -   Binarization of the image(s) by comparing to a fixed threshold.

Several or all of these steps may be omitted if applicable, for instanceif a sufficiently large optical sensor (e.g. a sensor with sufficientlylarge pixels) is used.

In a step 902, it is determined whether or not there is a change in thecaptured sub-image. For instance, the currently captured sub-image maybe compared to the previously captured sub-image(s) in order todetermine whether or not there is a change. Therein, the comparison topreviously captured sub-images may be limited to the sub-image of thepreviously captured sub-images that was captured immediately before thecurrent sub-image was captured and/or to the sub-images of thepreviously captured sub-images that were captured within a specifiedperiod of time (e.g. 0.1 seconds) before the current sub-image wascaptured. The comparison may be based on image analysis techniques suchas pattern recognition performed on the currently captured sub-image andon the previously captured sub-image. For instance, it may be analyzedwhether the pattern of the scale and/or the numbers visible through thedosage window 13 and shown in the currently captured sub-image and inthe previously captured sub-image is changed. For instance, it may besearched for patterns in the image that have a certain size and/oraspect ratio and these patterns may be compared with previously savedpatterns.

Steps 901 and 902 may correspond to a detection of a change in thecaptured image. If it is determined in step 902 that there is a changein the sub-image, step 901 is repeated.

Otherwise in a step 903, an image is captured by an optical sensor suchas optical sensor 25 of supplementary device 2. The captured image isfor instance an image of the dosage window 13 of injection device 1, inwhich a currently selected dose is displayed (e.g. by means of numbersand/or a scale printed on the sleeve 19 of injection device 1, which isvisible through the dosage window 13). For instance, the captured imagemay have a resolution being higher than the resolution of the capturedsub-image. The captured image at least shows the numbers printed on thesleeve 19 of injection device 1 which are visible through the dosagewindow 13.

In a step 904, an optical character recognition (OCR) is performed onthe image captured in step 903 in order to recognize the numbers printedon the sleeve 19 of injection device 1 and visible through the dosagewindow 13, because these numbers correspond to the (currently) selecteddose. In accord to the recognized numbers, the selected dose isdetermined, for instance by setting a value representing the selecteddose to the recognized numbers.

In a step 905, it is determined whether or not there is a change in thedetermined selected dose and, optionally, whether or not the determinedselected dose does not equal zero. For instance, the currentlydetermined selected dose may be compared to the previously determinedselected dose(s) in order to determine whether or not there is a change.Therein, the comparison to previously determined selected dose(s) may belimited to the previously determined selected dose(s) that weredetermined within a specified period of time (e.g. 3 seconds) before thecurrent selected dose was determined. If there is no change in thedetermined selected dose and, optionally, the determined selected dosedoes not equal zero, the currently determined selected dose isreturned/forwarded for further processing (e.g. to processor 24).

Thus, the selected dose is determined if the last turn of the dosageknob 12 is more than 3 seconds ago. If the dosage knob 12 is turnedwithin or after these 3 seconds and the new position remains unchangedfor more than 3 seconds, this value is taken as the determined selecteddose.

FIG. 5f shows in more detail method steps that are performed when theselected dose is determined based on the use of acoustical and opticalsensors. For instance, these steps may be performed in steps 502, 604and 704 of FIGS. 5a -c.

In a step 1001, a sound is captured by an acoustical sensor such asacoustical sensor 27 of supplementary device 2.

In a step 1002, it is determined whether or not the captured sound is aclick sound. The captured sound may for instance be a click sound thatoccurs when a dose is dialled by turning dosage knob 12 of injectiondevice 1 and/or when a dose is ejected/injected by pressing injectionbutton 11, and/or when a prime shot is performed. If the captured soundis not a click sound, step 1001 is repeated.

Otherwise in a step 1003, an image is captured by an optical sensor suchas optical sensor 25 of supplementary device 2. Step 1003 corresponds tostep 903 of flowchart 900.

In a step 1004, an OCR is performed on the image captured in step 1003.Step 1004 corresponds to step 904 of flowchart 900.

In a step 1005, it is determined whether or not there is a change in thedetermined selected dose and, optionally, whether or not the determinedselected dose does not equal zero. Step 1005 corresponds to step 905 offlowchart 900.

There might be a slight advantage of the acoustic approach shown in FIG.5f when it comes to power consumption of the supplementary device,because permanently capturing images or sub-images as shown in FIG. 5etypically is more power consuming than listening to an acoustical sensorsuch as a microphone.

FIG. 5g shows in more detail method steps that are performed when thedetermined selected dose is stored in a logbook.

In a step 1101, the currently selected dose is determined, for instancein accord with the steps of flowcharts 900 or 1000.

In a step 1102, it is determined whether the determined selected doseequals zero. If it does not equal zero, the value “inital dose” is setto the value of the determined selected dose in a step 1103.

Otherwise in a step 1104, it is determined whether or not the value“initial dose” has been defined previously. If it has not been definedpreviously, step 1101 is repeated.

Otherwise in a step 1105, the value “end dose” is set to the value ofthe determined selected dose.

In a step 1106, the difference between the values “initial dose” and“end dose” is displayed and, in a step 1107, the user is asked toconfirm the difference as injected.

If the user confirms the difference as injected, in a step 1108, thedifference is stored in the logbook as being injected, optionally atimestamp is added to the corresponding entry in the logbook.

If the user does not confirm the difference to be injected, in a step1109, the difference is stored in the logbook as being ejected,optionally a timestamp is added to the corresponding entry in thelogbook.

Thus, the “initial dose” is for instance detected if the last turn ofthe dosage knob is more than 3 seconds ago. If the dosage knob is turnedwithin or after these 3 seconds and the new position remains unchangedfor more than 3 seconds, the correspondingly detected value is taken as“initial dose”. If the determined selected dose equals zero and an“initial dose” other than zero was defined, the value of “initial dose”is displayed and the user is asked to confirm the displayed value asbeing injected.

A user confirmation of the selected dose in step 1107 may be necessaryto distinguish between the dose ejected during the safety test (priming)and the actually injected dose.

The safety test is mostly a mandatory step in the application sequence.A distinction between the dose ejected during the priming and theactually injected dose can be implemented in different ways:

1. The user activates the supplementary device 2 after the safety test810 but before the actual injection procedure 820. However, as thesupplementary device 2 blocks the view of the dosage window 13 the usercannot check before the safety test 810 the initially selected dose andduring the safety test 810 whether the selected dose is two units andafter the safety test whether the dose is set to zero again.Furthermore, the dose ejected during the priming cannot be stored tomonitor the amount of insulin left in the cartridge.2. The user activates the supplementary device 2. The first determinedselected dose is shown on the display, but it is not stored in thelogbook as injected. Any further selected and ejected dose is stored asinjected.

However, for users who either skip the priming or add two units to theselected dose that they would like to eject prior to the injection ofthe needle, the supplementary device 2 does not store the injected dosecorrectly. Users who repeat the priming create incorrect dosagerecordings.

3. The user activates the supplementary device 2, the first determinedselected dose is compared to the value two and if true, it is notstored. Any further dose is stored.

However, for users who either skip the priming or add two units to theselected dose that they would like to eject prior to the injection ofthe needle, the supplementary device 2 does also not store the injecteddose correctly. Users who repeat the priming also create incorrectrecordings. If the users does not stick to the value of two units forthe safety test this might also result in incorrect recordings.

4. The user activates the supplementary device 2. As long as thedetermined selected dose is equal to the value two, the dose is notstored. Any further dose is stored.

However, for users who add two units to the selected dose that theywould like to eject prior to the injection of the needle, thesupplementary device 2 does not record the injected dose correctly. Aninsulin dose of two will not be properly recorded.

5. The user activates the supplementary device 2. The dose is recordedfor the safety test 810 and for the actual injection 820. The dose isonly stored as being injected if the user acknowledges the determinedselected dose(s) (e.g. the difference of “initial value” and “endvalue”) as correct and/or as injected. Otherwise, the determinedselected dose(s) may be corrected and/or stored as ejected to monitorthe amount of insulin left in the cartridge.

Only this implementation of an acknowledgement by the user may beversatile enough to cover the many possible actions of the user duringthe application sequence. An acknowledgement of the user that thedetermined selected dose is correct and that the dose was reallyinjected into the body additionally closes loopholes that exist if thesequence of user action differs substantially from what is shown in FIG.5 d.

For instance, there exist several application sequences that may lead toan incorrect determination and storage of the selected dose, when thedetermined selected dose is not acknowledged:

-   -   For instance, when the user dials a dose, waits for a specified        period of time (e.g. 3 seconds) and turns the dosage knob to        zero without ejecting/injecting the dialled dose, the selected        dose may however be determined as ejected/injected.    -   For instance, when the user dials a dose, waits for a specified        period of time (e.g. more than 3 seconds), injects the dialled        dose partially, waits for a specified period of time (e.g. more        than 3 seconds), injects the remaining part of the dialled dose,        the determined selected dose may be smaller than the injected        dose.    -   For instance, when the user dials a dose, waits less than a        specified period of time (e.g. less than 3 seconds), injects the        dialled dose entirely, the selected dose may not be determined.        When the user repeats this sequence, the determined selected        dose may be smaller than the injected dose.    -   For instance, if the user dials a dose, waits for a specified        period of time (e.g. 3 seconds), injects the dialled dose        entirely, waits less than a specified period of time (e.g. less        than 1 seconds) before repeating this sequence, the determined        selected dose may be smaller than the injected dose.

To make it obvious for a user that he is expected to wait for aspecified period of time, display 21 could flash while displaying thedetermined selected dose for the specified period of time and switch toa non-flashing/permanent mode thereafter.

FIG. 6 is a schematic illustration of a tangible storage medium 60 (acomputer program product) that comprises a computer program 61 withprogram code 62 according to an embodiment of the present invention.This program code may for instance be executed by processors containedin the supplementary device, for instance processor 24 of supplementarydevice 2 of FIGS. 2a and 4, but also of a processor of supplementarydevice 3 of FIG. 2b . For instance, storage medium 60 may representprogram memory 240 of supplementary device 2 of FIG. 4. Storage medium60 may be a fixed memory, or a removable memory, such as for instance amemory stick or card.

Finally, FIG. 7 is an information sequence chart 7 that illustrates theflow of information between various devices (e.g. the injection device 1and the supplementary device 2 of FIG. 4 in a scenario as depicted inFIG. 3a or 3 b) according to an embodiment of the present invention.

A condition and/or use of injection device 70 affects an appearance ofits dosage window, sounds generated by injection device 70 and a colourof the housing. This information is transformed by sensors 710 ofsupplementary device 71 into an OCR signal, an acoustic sensor signaland a photometer signal, respectively, which are in turn transformedinto information on the dialled dose, on an injection/dialling operationand on the type of insulin by a processor 711 of supplementary device71, respectively. This information is then provided by supplementarydevice 70 to a blood glucose monitoring system 73, and may also bedisplayed to a user 72 via an LCD signal. Furthermore, informationrelated to a proposed next injection is optionally transmitted fromblood glucose monitoring system 73 to supplementary device 71 (and mayalso be displayed to user 72).

As described in detail above, embodiments of the present invention allowconnection of a standard injection device, in particular an insulindevice, with a blood glucose monitoring system in a useful andproductive way.

Embodiments of the present invention introduce a supplementary device toallow for this connection, assuming the blood glucose monitoring systemhas wireless or other communication capabilities. Other embodiments showthat the blood glucose monitoring system is included into thesupplementary device.

The benefits from the connection between the blood glucose monitoringand an insulin injection device are inter alia the reduction of mistakesby the user of the injection device and a reduction of handling steps—nomore manual transfer of the injected insulin unit to a blood glucosemonitoring is required, in particular to a blood glucose monitoringsystem with functionality of providing guidance for the next dose basedon the last dose injected and latest blood glucose values.

As described with reference to exemplary embodiments above, when auser/patient gets a new insulin pen, the user attaches the supplementarydevice to the pen. The supplementary device reads out the injected doseand transfers it to a blood glucose monitoring system with insulintitration capabilities. The blood glucose monitoring system may alsotransmit the recommended next dose to be taken to the supplementarydevice e.g. to check whether the recommended dose is identical with theinjected dose or not. For patients taking multiple insulins, thesupplementary device recognizes the device structure to the insulin typeand may also transmit this piece of information to the blood glucosemonitoring system.

In an example embodiment, the information shown on a display, forexample LCD display 21 of FIGS. 2a and 4 or display 32 of FIG. 2b , mayalso converted to a sound signal played to a user through a speaker, forexample by a text-to-speech functionality implemented by processor 24.Thus, a user with impaired vision may have improved access to theinformation of supplementary devices 2 or 3, such as a dialled dose, arecommended dose, a recommended time for administration and/or the like.

When using embodiments of the present invention, the user inter alia hasthe following advantages:

The user can use the most convenient disposable insulin injector.

The supplementary device is attachable and detachable (reusable).

Injected dose information may be transferred to the blood glucosemonitoring system automatically (no more transfer mistakes).

Improved dose guidance may result from this as the blood glucosemonitoring system calculates the dose to be taken.

Keeping of a manual data logbook may not be needed any more.

Furthermore, when deploying the supplementary device proposed by thepresent invention, patients may also be reminded of injecting their nextdose by receiving an alarm signal, for instance, after an appropriatetime after a first dose of a medicament (for instance insulin orheparin) has been injected.

Injected dose information may be transferred to any computerized system,for instance as input for any dose calculation or any other applicabletherapeutic guidance calculation, or for the creation of an alarmsignal, for instance to remind the user of taking the next dose.

The term “medicament”, as used herein, means a pharmaceuticalformulation containing at least one pharmaceutically active compound,

wherein in one embodiment the pharmaceutically active compound has amolecular weight up to 1500 Da and/or is a peptide, a protein, apolysaccharide, a vaccine, a DNA, a RNA, a antibody, an enzyme, anantibody, a hormone or an oligonucleotide, or a mixture of theabove-mentioned pharmaceutically active compound,wherein in a further embodiment the pharmaceutically active compound isuseful for the treatment and/or prophylaxis of diabetes mellitus orcomplications associated with diabetes mellitus such as diabeticretinopathy, thromboembolism disorders such as deep vein or pulmonarythromboembolism, acute coronary syndrome (ACS), angina, myocardialinfarction, cancer, macular degeneration, inflammation, hay fever,atherosclerosis and/or rheumatoid arthritis,wherein in a further embodiment the pharmaceutically active compoundcomprises at least one peptide for the treatment and/or prophylaxis ofdiabetes mellitus or complications associated with diabetes mellitussuch as diabetic retinopathy,wherein in a further embodiment the pharmaceutically active compoundcomprises at least one human insulin or a human insulin analogue orderivative, glucagon-like peptide (GLP-1) or an analogue or derivativethereof, or exedin-3 or exedin-4 or an analogue or derivative ofexedin-3 or exedin-4.

Insulin analogues are for example Gly(A21), Arg(B31), Arg(B32) humaninsulin; Lys(B3), Glu(B29) human insulin; Lys(B28), Pro(B29) humaninsulin; Asp(B28) human insulin; human insulin, wherein proline inposition B28 is replaced by Asp, Lys, Leu, Val or Ala and wherein inposition B29 Lys may be replaced by Pro; Ala(B26) human insulin;Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) humaninsulin.

Insulin derivates are for example B29-N-myristoyl-des(B30) humaninsulin; B29-N-palmitoyl-des(B30) human insulin; B29-N-myristoyl humaninsulin; B29-N-palmitoyl human insulin; B28-N-myristoyl LysB28ProB29human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin;B30-N-myristoyl-ThrB29LysB30 human insulin; B30-N-palmitoyl-ThrB29LysB30human insulin; B29-N—(N-palmitoyl-Y-glutamyl)-des(B30) human insulin;B29-N—(N-lithocholyl-Y-glutamyl)-des(B30) human insulin;B29-N-(ω-carboxyheptadecanoyl)-des(B30) human insulin andB29-N-(ω-carboxyhepta-decanoyl) human insulin.

Exendin-4 for example means Exendin-4(1-39), a peptide of the sequence HHis-Gly-Glu-Gly-Thr-Phe-Thr-Ser-Asp-Leu-Ser-Lys-Gln-Met-Glu-Glu-Glu-Ala-Val-Arg-Leu-Phe-Ile-Glu-Trp-Leu-Lys-Asn-Gly-Gly-Pro-Ser-Ser-Gly-Ala-Pro-Pro-Pro-Ser-NH2.

Exendin-4 derivatives are for example selected from the following listof compounds:

H-(Lys)4-des Pro36, des Pro37 Exendin-4(1-39)-NH2,

H-(Lys)5-des Pro36, des Pro37 Exendin-4(1-39)-NH2,

des Pro36 [Asp28] Exendin-4(1-39),

des Pro36 [IsoAsp28] Exendin-4(1-39),

des Pro36 [Met(O)14, Asp28] Exendin-4(1-39),

des Pro36 [Met(O)14, IsoAsp28] Exendin-4(1-39),

des Pro36 [Trp(O2)25, Asp28] Exendin-4(1-39),

des Pro36 [Trp(O2)25, IsoAsp28] Exendin-4(1-39),

des Pro36 [Met(O)14 Trp(O2)25, Asp28] Exendin-4(1-39),

des Pro36 [Met(O)14 Trp(O2)25, IsoAsp28] Exendin-4(1-39); or

des Pro36 [Asp28] Exendin-4(1-39),

des Pro36 [IsoAsp28] Exendin-4(1-39),

des Pro36 [Met(O)14, Asp28] Exendin-4(1-39),

des Pro36 [Met(O)14, IsoAsp28] Exendin-4(1-39),

des Pro36 [Trp(O2)25, Asp28] Exendin-4(1-39),

des Pro36 [Trp(O2)25, IsoAsp28] Exendin-4(1-39),

des Pro36 [Met(O)14 Trp(O2)25, Asp28] Exendin-4(1-39),

des Pro36 [Met(O)14 Trp(O2)25, IsoAsp28] Exendin-4(1-39),

wherein the group -Lys6-NH2 may be bound to the C-terminus of theExendin-4 derivative;

or an Exendin-4 derivative of the sequence

H-(Lys)6-des Pro36 [Asp28] Exendin-4(1-39)-Lys6-NH2,

des Asp28 Pro36, Pro37, Pro38Exendin-4(1-39)-NH2,

H-(Lys)6-des Pro36, Pro38 [Asp28] Exendin-4(1-39)-NH2,

H-Asn-(Glu)5des Pro36, Pro37, Pro38 [Asp28] Exendin-4(1-39)-NH2,

des Pro36, Pro37, Pro38 [Asp28] Exendin-4(1-39)-(Lys)6-NH2,

H-(Lys)6-des Pro36, Pro37, Pro38 [Asp28] Exendin-4(1-39)-(Lys)6-NH2,

H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Asp28] Exendin-4(1-39)-(Lys)6-NH2,

H-(Lys)6-des Pro36 [Trp(O2)25, Asp28] Exendin-4(1-39)-Lys6-NH2,

H-des Asp28 Pro36, Pro37, Pro38 [Trp(O2)25] Exendin-4(1-39)-NH2,

H-(Lys)6-des Pro36, Pro37, Pro38 [Trp(O2)25, Asp28] Exendin-4(1-39)-NH2,

H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Trp(O2)25, Asp28]Exendin-4(1-39)-NH2,

des Pro36, Pro37, Pro38 [Trp(O2)25, Asp28] Exendin-4(1-39)-(Lys)6-NH2,

H-(Lys)6-des Pro36, Pro37, Pro38 [Trp(O2)25, Asp28]Exendin-4(1-39)-(Lys)6-NH2,

H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Trp(O2)25, Asp28]Exendin-4(1-39)-(Lys)6-NH2,

H-(Lys)6-des Pro36 [Met(O)14, Asp28] Exendin-4(1-39)-Lys6-NH2,

des Met(O)14 Asp28 Pro36, Pro37, Pro38 Exendin-4(1-39)-NH2,

H-(Lys)6-desPro36, Pro37, Pro38 [Met(O)14, Asp28] Exendin-4(1-39)-NH2,

H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Met(O)14, Asp28]Exendin-4(1-39)-NH2,

des Pro36, Pro37, Pro38 [Met(O)14, Asp28] Exendin-4(1-39)-(Lys)6-NH2,

H-(Lys)6-des Pro36, Pro37, Pro38 [Met(O)14, Asp28]Exendin-4(1-39)-(Lys)6-NH2,

H-Asn-(Glu)5 des Pro36, Pro37, Pro38 [Met(O)14, Asp28]Exendin-4(1-39)-(Lys)6-NH2,

H-Lys6-des Pro36 [Met(O)14, Trp(O2)25, Asp28] Exendin-4(1-39)-Lys6-NH2,

H-des Asp28 Pro36, Pro37, Pro38 [Met(O)14, Trp(O2)25]Exendin-4(1-39)-NH2,

H-(Lys)6-des Pro36, Pro37, Pro38 [Met(O)14, Asp28] Exendin-4(1-39)-NH2,

H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Met(O)14, Trp(O2)25, Asp28]Exendin-4(1-39)-NH2,

des Pro36, Pro37, Pro38 [Met(O)14, Trp(O2)25, Asp28]Exendin-4(1-39)-(Lys)6-NH2,

H-(Lys)6-des Pro36, Pro37, Pro38 [Met(O)14, Trp(O2)25, Asp28]Exendin-4(S1-39)-(Lys)6-NH2,

H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Met(O)14, Trp(O2)25, Asp28]Exendin-4(1-39)-(Lys)6-NH2;

or a pharmaceutically acceptable salt or solvate of any one of theafore-mentioned Exedin-4 derivative.

Hormones are for example hypophysis hormones or hypothalamus hormones orregulatory active peptides and their antagonists as listed in RoteListe, ed. 2008, Chapter 50, such as Gonadotropine (Follitropin,Lutropin, Choriongonadotropin, Menotropin), Somatropine (Somatropin),Desmopressin, Terlipressin, Gonadorelin, Triptorelin, Leuprorelin,Buserelin, Nafarelin, Goserelin.

A polysaccharide is for example a glucosaminoglycane, a hyaluronic acid,a heparin, a low molecular weight heparin or an ultra low molecularweight heparin or a derivative thereof, or a sulphated, e.g. apoly-sulphated form of the above-mentioned polysaccharides, and/or apharmaceutically acceptable salt thereof. An example of apharmaceutically acceptable salt of a poly-sulphated low molecularweight heparin is enoxaparin sodium.

Pharmaceutically acceptable salts are for example acid addition saltsand basic salts. Acid addition salts are e.g. HCl or HBr salts. Basicsalts are e.g. salts having a cation selected from alkali or alkaline,e.g. Na+, or K+, or Ca2+, or an ammonium ion N+(R1)(R2)(R3)(R4), whereinR1 to R4 independently of each other mean: hydrogen, an optionallysubstituted C1 C6-alkyl group, an optionally substituted C2-C6-alkenylgroup, an optionally substituted C6-C10-aryl group, or an optionallysubstituted C6-C10-heteroaryl group. Further examples ofpharmaceutically acceptable salts are described in “Remington'sPharmaceutical Sciences” 17. ed. Alfonso R. Gennaro (Ed.), MarkPublishing Company, Easton, Pa., U.S.A., 1985 and in Encyclopedia ofPharmaceutical Technology.

Pharmaceutically acceptable solvates are for example hydrates.

The invention has been described above by means of embodiments, whichshall be understood to be non-limiting examples only. In particular, itshould be noted that there are alternative ways and variations which areobvious to a skilled person in the art and can be implemented withoutdeviating from the scope and spirit of the appended claims.

It should also be understood that the sequence of method steps in theflowcharts presented above is not mandatory, also alternative sequencesmay be possible. All functional blocks of apparatuses shall also beunderstood as a disclosure of an according method step, and similarly,each method step shall be considered as a disclosure of an accordingfunctional unit of an apparatus. It is well understood that the methodsteps and functional components can be implemented in various wayseither in hardware only, or in software only, or in a combination ofhard- and software.

In particular, the following embodiments of aspects of the presentinvention are to be disclosed.

Embodiment 1

An apparatus (2, 3), comprising

-   -   a mating unit (20-1, 20-2; 31) for releasably attaching the        apparatus (2) to a medical device (1) or for releasably        receiving at least a part of the medical device (1), and    -   one or more optical sensors (25, 26) and/or one or more        acoustical sensors (27) for determining information related to a        condition and/or use of the medical device (1).

Embodiment 2

The apparatus (2, 3) according to embodiment 1, wherein the one or moreoptical sensors (25, 26) comprise at least one optical sensor (25)configured to capture an image of an information-bearing orinformation-displaying (13) part of the medical device (1).

Embodiment 3

The apparatus (2, 3) according to embodiment 2, wherein the apparatus(2, 3) is configured to recognize characters from the captured image.

Embodiment 4

The apparatus (2, 3) according to any of the embodiments 1-3, whereinthe one or more optical sensors (25, 26) comprise at least one opticalsensor (26) configured to capture information representative of a colourof at least a part (10) of the medical device (1) or to determine acolour of at least a part of the medical device (1).

Embodiment 5

The apparatus (2, 3) according to embodiment 4, wherein the apparatus(2, 3) is configured to recognize a colour of the part (10) of themedical device (1) from the captured information.

Embodiment 6

The apparatus (2, 3) according to any of the embodiments 1-5, whereinthe one or more acoustical sensors (27) comprise at least one acousticalsensor (27) configured to capture a sound produced when the medicaldevice (1) is used.

Embodiment 7

The apparatus (2, 3) according to embodiment 6, wherein the apparatus(2, 3) is configured to recognize, from the captured sound, at least anejection of a medicament performed with the medical device (1).

Embodiment 8

The apparatus (2, 3) according to any of the embodiments 1-7, furthercomprising a display unit (21) for displaying information representativeof at least a part of the determined information.

Embodiment 9

The apparatus (2, 3) according to any of the embodiments 1-8, furthercomprising an interface (28) configured to provide the determinedinformation to another device 42, 42′) via a wired or wirelessconnection.

Embodiment 10

The apparatus (2, 3) according to any of the embodiments 1-9, furthercomprising an interface (28) configured to receive informationindicative of a type and/or dose of medicament to be ejected.

Embodiment 11

The apparatus according to any of the embodiments 1-10, furthercomprising a processor (24) for determining a proposal of a type and/ordose of a medicament to be ejected by the medical device.

Embodiment 12

The apparatus according to any of the embodiments 1-11, furthercomprising a measurement unit (29) for measuring at least one parameterthat is representative of a condition of a creature that is to receive amedicament ejectable by the medical device.

Embodiment 13

A system, comprising a medical device (1) and an apparatus (2, 3)according to any of the embodiments 1-12.

Embodiment 14

A method (500, 600, 700), comprising

-   -   determining, based on information captured by one or more        optical sensors (25, 26) and/or one or more acoustical sensors        (27), information related to a condition and/or use of a medical        device (1), wherein the sensors (25, 26, 27) are comprised in an        apparatus (2, 3) that further comprises a mating unit (20-1,        20-2; 31) for releasably attaching the apparatus (2) to the        medical device (1) or for releasably receiving at least a part        of the medical device (1).

Embodiment 15

A computer program (61), comprising instructions operable to cause aprocessor (24) to perform the method (500, 600, 700) of embodiment 14when the computer program (61) is executed on the processor (24).

The invention claimed is:
 1. An apparatus, comprising: a mating unit forreleasably attaching the apparatus to a medical device for ejecting amedicament or for releasably receiving at least a part of the medicaldevice; an optical sensor configured to capture an image of aninformation-bearing or information-displaying part of the medicaldevice, the captured image comprising a character; a wireless unitconfigured for transmitting the captured image of theinformation-bearing or information-displaying part of the medical deviceto another device; and a processor configured to monitor a timedifference between an end time of dialing a dose of the medicament and acurrent time.
 2. The apparatus according to claim 1, wherein theapparatus is configured to recognize the character from the capturedimage.
 3. The apparatus according to claim 1, wherein the apparatus isconfigured to recognize the character from the captured image usingoptical character recognition.
 4. The apparatus according to claim 1,wherein the mating unit includes a recess or an opening, wherein therecess or the opening is configured to at least partially receive themedical device.
 5. The apparatus according to claim 1, wherein theapparatus is configured to monitor at least a portion of an applicationsequence of applying the medicament by the medical device.
 6. Theapparatus according to claim 1, wherein the optical sensor is a firstoptical sensor, and wherein a second optical sensor is configured tocapture information representing a color of at least a part of themedical device or is configured to determine a color of at least a partof the medical device.
 7. The apparatus according to claim 6, whereinthe apparatus is configured to recognize the color of the part of themedical device from a second image captured by the second opticalsensor.
 8. The apparatus according to claim 1, further comprising one ormore acoustical sensors, wherein the one or more acoustical sensorscomprise at least one acoustical sensor configured to capture a soundproduced when the medical device is used.
 9. The apparatus according toclaim 8, wherein the apparatus is configured to capture the image of theinformation-bearing or information-displaying part of the medical deviceor to recognize characters captured in the image only if the one or moreacoustical sensors captures a sound produced when a dose for amedicament to be ejected by the medical device is dialled.
 10. Theapparatus according to claim 1, wherein the apparatus is configured todetermine that the time difference exceeds a specified period of time,and in response, recognize that a captured image corresponds to a doseselected by a user.
 11. The apparatus according to claim 1, furthercomprising one or more light sources to illuminate a dosage window ofthe medical device.
 12. The apparatus according to claim 1, wherein aninterface is configured to transmit the captured image to the device viaa wireless connection.
 13. The apparatus according to claim 1, whereinthe apparatus is configured to trigger transmission of information fromthe apparatus to the other device.
 14. The apparatus according to claim1, further comprising a display unit to display information to a user.15. The apparatus according to claim 1, further comprising a memory forstoring data determined from the captured image.
 16. A system,comprising the medical device and the apparatus according to claim 1.17. The system according to claim 16, wherein the medical device is aninjection pen or an infusion pump.
 18. The system according to claim 16,wherein a display of the medical device is at least partially covered bythe optical sensor of the apparatus.
 19. The apparatus to claim 1,further comprising another optical sensor configured to determine anoptical property of a housing of the medical device, wherein thewireless unit is configured to, based on the captured image and thedetermined optical property of the housing, transmit data indicative ofa selected dose to the another device.
 20. The apparatus to claim 1,wherein the optical sensor is configured to capture the image of theinformation-bearing or information-displaying part of the medical devicebased on an acoustic signal produced by the apparatus.
 21. The apparatusto claim 1, further comprising a sensor configured to detect an ejectionof the medicament has been performed, wherein the wireless unit isconfigured to, in response to a detection of the ejection of themedicament has been performed and based on the captured image, transmitdata indicative of a selected dose to the another device.
 22. A methodof operating an apparatus comprising a mating unit for releasablyattaching the apparatus to a medical device for ejecting a medicament orreleasably receiving at least a part of the medical device, an opticalsensor, a wireless unit, and a processor, the method comprising:capturing, by the optical sensor of the apparatus, an image of aninformation-bearing or information-displaying part of the medicaldevice, the captured image comprising a character; transmitting, by thewireless unit of the apparatus, the captured image of theinformation-bearing or information-displaying part of the medical deviceto another device; and monitoring, by the processor of the apparatus, atime difference between an end time of dialling a dose of the medicamentand a current time.
 23. A computer program, comprising instructionsoperable to cause a processor of an apparatus to perform operations whenthe computer program is executed on the processor, wherein the apparatuscomprises a mating unit for releasably attaching the apparatus to amedical device for ejecting a medicament or for releasably receiving atleast a part of the medical device, an optical sensor, and a wirelessunit, wherein the operations comprise: capturing, by the optical sensorof the apparatus, an image of an information-bearing orinformation-displaying part of the medical device, the captured imagecomprising a character; transmitting, by the wireless unit of theapparatus, the captured image the information-bearing orinformation-displaying part of the medical device to another device; andmonitoring, by the processor of the apparatus, a time difference betweenan end time of dialling a dose of the medicament and a current time.